NCT02281305Unknown4 期
Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
G.Gennimatas General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Degree of inflammation of the involved myocardium as assessed by the PET scan
研究概览
简要总结
Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will enroll patients 18 years old or older
- •Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation > 1 mm in two contiguous limb leads or ST segment elevation > 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.
排除标准
- •Excluded patients:
- •with age > 80 years old
- •with active inflammatory diseases, infectious diseases or known malignancy
- •under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
- •with known hypersensitivity-allergy to colchicine
- •under chronic treatment with colchicine
- •with severe renal failure (eGFR < 30 ml/min/1.73 m2)
- •with hepatic failure (Child - Pugh class B or C)
- •presented with cardiac arrest
- •presented with ventricular fibrillation
- •presented with cardiogenic shock
- •with stent thrombosis
- •with angina within 48 hours before infarction
- •with previous myocardial infarction in the affected territory
- •with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
研究组 & 干预措施
Colchicine Active treatment group
Experimental
Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
干预措施: Colchicine (Drug)
结局指标
主要结局
Degree of inflammation of the involved myocardium as assessed by the PET scan
时间窗: 5 days post-MI
次要结局
未报告次要终点
研究者
Spyridon Deftereos
Director, Cardiac Catheterization Department
G.Gennimatas General Hospital
研究点 (1)
Loading locations...
相似试验
终止
不适用
Resistance STEMI StudyAcute Myocardial InfarctionSTEMINCT03439150Catharina Ziekenhuis Eindhoven5
已完成
1 期
Neuroinflammation After Myocardial Infarction - Imaging SubstudyMyocardial InfarctionNCT03968445University of Alabama at Birmingham6
进行中（未招募）
1 期
Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine. Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in patients with Chronic Ischaemic Heart Failure (CIHF)Chronic Ischaemic Heart Failure (CIHF)MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2016-004683-19-PLKrakowski Szpital Specjalistyczny im. Jana Pawla II
进行中（未招募）
1 期
Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with acute myocardial infarction (AMI).AMI: Acute Myocardial InfarctionMedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersEUCTR2016-004662-25-PLKrakowski Szpital Specjalistyczny im. Jana Pawla II115
进行中（未招募）
1 期
Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with no-option critical limb ischemia (N-O CLI).EUCTR2016-004684-40-PLKrakowski Szpital Specjalistyczny im. Jana Pawla II115